DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S,…
Medical device recall Z-3069-2017. Published in FDA’s Enforcement Report on Aug 30, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 30, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 47 states named in where it went
- 86,024 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
86,024, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 3387, Lot Serial #: 0206880294, 0206882647, 0206882779, 0206882780, 0206882781, 0206882782, 0206882783, 0206886184, 0206886323, 0206886328, 0206886330, 0206886331, 0206886332, 0206886333, 0206886603, 0206887813, 0206890443,…
Every code shown here, 1,994 characters
Model 3387, Lot Serial #: 0206880294, 0206882647, 0206882779, 0206882780, 0206882781, 0206882782, 0206882783, 0206886184, 0206886323, 0206886328, 0206886330, 0206886331, 0206886332, 0206886333, 0206886603, 0206887813, 0206890443, 0206890444, 0206903488, 0206903489, 0206906792, 0206906793, 0206907159, 0206916391, 0206916392, 0206916393, 0206916394, 0206916395, 0206916396, 0206916397, 0206916398, 0206916399, 0206916797, 0206917120, 0206917121, 0206917122, 0206917123, 0206917124, 0206917125, 0206917126, 0206917127, 0206917128, 0206917129, 0206917130, 0206917131, 0206917132, 0206917302, 0206917303, 0206917304, 0206917306, 0206917307, 0206917308, 0206917310, 0206917312, 0206917560, 0206917561, 0206917563, 0206917564, 0206917565, 0206917566, 0206917568, 0206917569, 0206917570, 0206917572, 0206917573, 0206917574, 0206917575, 0206917576, 0206917577, 0206917578, 0206917579, 0206917620, 0206917621, 0206917622, 0206917623, 0206917624, 0206917625, 0206917626, 0206917627, 0206917628, 0206917629, 0206917630, 0206917631, 0206917632, 0206917633, 0206917634, 0206917635, 0206917636, 0206917637, 0206917638, 0206917639, 0206917660, 0206917661, 0206917662, 0206917663, 0206917664, 0206917665, 0206917666, 0206917667, 0206917668, 0206917669, 0206917670, 0206917671, 0206920443, 0206920444, 0206920445, 0206920447, 0206920448, 0206920449, 0206920450, 0206920451, 0206920452, 0206920453, 0206920454, 0206920455, 0206920456, 0206920457, 0206920458, 0206920459, 0206920460, 0206920461, 0206920462, 0206920463, 0206920663, 0206920664, 0206920665, 0206920666, 0206920667, 0206920668, 0206920669, 0206920670, 0206920671, 0206920672, 0206920673, 0206924158, 0206924492, 0206924493, 0206924494, 0206924604, 0206924605, 0206924606, 0206924607, 0206924608, 0206924609, 0206924610, 0206924611, 0206924612, 0206924613, 0206924614, 0206924615, 0206924616, 0206924617, 0206924618, 0206924619, 0206925140, 0206925141, 0206925142, 0206925143, 0206925245, 0206925290, 0206925291, 0206925292, 0206926111, 0206926112,…
FDA’s list runs to 101,017 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, China, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Indonesia, Vietnam, Albania, Algeria, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Mexico, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
The states and territories these words name
47 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 17, 2017.
- FDA classified it on Aug 23, 2017.
- FDA’s Enforcement Report published it on Aug 30, 2017.
- FDA terminated it on Apr 22, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neuromodulation, of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 101,017 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.